Trial Information

An Exploratory Phase I Study With Sorafenib in Addition to Vinflunine in Progressive Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Objectives

- To explore the safety of sorafenib in combination with vinflunine in patients with
transitional cell carcinoma of the urothelial tract and to define a recommended phase
II dose for this treatment combination

- To correlate early tracer 18F-FDG-PET/CT functional imaging readouts with standard
RECIST (version 1.1) evaluations with the intention to explore new endpoints for
targeted therapy

- To evaluate serum and urine markers of apoptosis as potential markers of
sorafenib/vinflunine treatment

Rationale/Goal

To evaluate the tolerability and activity of sorafenib combined with vinflunine in patients
with advanced or metastatic urothelial cancer.

Tumour biopsies will be collected before and after one cycle of therapy. The translational
part of this study aims to explore the predictive value of a number of biomarkers related to
the targeted properties of sorafenib and presumptive markers for vinflunine treatment.

In addition, the predictive value of an early functional imaging tracer 18F-FDG-PET/CT will
be evaluated.

Inclusion Criteria:

- patients who have received neoadjuvant or adjuvant platinum-containing chemotherapy
and who are diagnosed with locoregional recurrent or metastatic disease prior to or
at the 6-months‟ visit , are eligible or

- patients who have received palliative platinum-containing chemotherapy and who are
diagnosed with progression prior to or at the 6-months‟ visit, are eligible or

- patients who have contraindication to platinum-containing chemotherapy;

- previous systemic chemotherapy must have been stopped 14 days before the inclusion
with recovery (G1 or less) from any treatment related toxicity;

- measurable and/or non-measurable disease using RECIST and defined as: Measurable
disease: lesions that can be measured in at least one dimension and which have not
been previously irradiated. Longest diameter 20 mm with conventional techniques or 10
mm with spiral CT scan or MRI. Non-measurable disease: lesions which have not been
previously irradiated, or longest diameter <20 mm with conventional techniques or <10
mm with spiral CT scan or MRI, or truly non measurable lesions including bone
lesions, ascites, pleural/pericardial effusion, and lymphangitis cutis/pulmonitis;

Name

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